DESCRIPTION: As the end-of-life approaches, the frequency of cancer increases markedly and it has been estimated that approximately 400,000 persons each year suffer oral side effects as a consequence of being treated for cancer therapy. Oral mucositis, an inflammatory condition of the oral mucosa leading to atrophy and ulceration, is one of the conditions frequently seen in those patients undergoing anti-cancer therapy. The lesions first appear in the mucosa of the soft palate, tongue and cheeks and as they enlarge lead to extreme pain and dysphagia. As a consequence, there may be dehydration, a compromised nutritional status and a decreased quality of life. Palliation represents the standard clinical management so as to relieve symptoms and to check infections by means of anesthetic and antibiotic rinses. The hypothesis underlying the proposed research is that an appropriate occlusive muco-adhesive will not only reduce the symptoms of mucositis but could provide a means for effective adjunctive therapy of the condition. This application as an R21 exploratory and developmental grant seeks to develop an occlusive muco-adhesive in both gel and film form for the treatment of oral mucositis based on the biocompatible polymer, chitosan. The investigators intend to explore the effectiveness of the muco-adhesive in-vitro for delivering the antimicrobial and anti-inflammatory compounds necessary for palliative therapy of mucositis as well as for delivering bioactive peptides that may be able to provide protection or promote healing of the oral mucosa. Finally, they will investigate the acceptability, substantivity and durability of the muco-adhesive in vivo using normal mucosa and examine its effects on ulcerated mucosa in human volunteers. The study will involve collaborative studies between investigators with expertise in pharmaceutical technology, oral mucosal biology and oral medicine so as to develop palliative and therapeutic approaches to mucositis that would be of great benefit in improving the quality of life of those who are frequently at the end-of-life.